The present invention relates to a packaged article usually meant to be sterile or clean, and more particularly concerns a packaged syringe which includes evidence that the package seal has been broken so that the user knows that its sterility or cleanliness has been compromised.
Clean or sterile articles particularly useful for medical applications are packaged to preserve this sterility. The packages for these articles are intended to provide a bacteria barrier to prevent bacteria from entering inside the package to contaminate its contents. In most instances, the package is opened immediately prior to using a sterile article such as a syringe so as to minimize the time period which the sterile article is exposed. There are, however, instances when a clean or sterile article may be removed from its barrier package and, perhaps not be used at the time of initial opening. For this and a variety of other reasons, users of these sterile articles are often able to reassemble the syringe or like device back into the package from which it was removed. Upon this reassembly, however, no resterilization technique is performed so that the article may be exposed to a contamination path for an extended period of time. When either the same user or another user attempts to use this previously opened medical article, it may not be possible to tell whether or not it had been opened once before. In this event, the user may presume that the article is still sterile, if there is no knowledge that the package had been previously opened. On the other hand, the opposite conclusion should have been arrived at, namely, that the previously opened article would indicate that sterility has been compromised and that the article is no longer clean for its intended use. Therefore, a clear mechanism to establish evidence that a packaged sterile article has been opened is a desired feature in the use of these kinds of articles.
In U.S. Pat. Nos. 3,333,682; 3,272,322 and 2,884,123, medical devices are described which include some evidence that the sterile article has been previously removed from the package. However, in those patents, the container itself is broken with no evidence remaining upon the originally contained article that the article has been removed from a clean or sterile package. In U.S. Pat. No. 4,181,223, a syringe is completely coated with a film that is broken at the cap end or the plunger end by the user just before use. Although portions of the broken film remain attached to the syringe barrel after the seal is broken, the application of the film to the entire syringe assembly can be overly complicated, expensive and difficult to manage. In this case, when the user merely has the article itself in hand, it cannot be ascertained whether or not that article has been used previously or perhaps otherwise presumed contaminated. Accordingly, it can be seen that there is still a strong need for positive evidence in conjunction with sterile articles such as syringes and the like that they have been removed from the original package to thereby serve as an unequivocal indication that sterility or cleanliness has been compromised.